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Clinical Trials/NCT03623477
NCT03623477CompletedNot Applicable

Can Cognitive Training Decrease Reactive Aggression? The Role of Improved Emotion Regulation, Emotion Awareness, and Impulse Control

Weill Medical College of Cornell University2 sites in 1 country90 target enrollmentStarted: August 16, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
90
Locations
2
Primary Endpoint
Change in Aggression

Study Overview

Brief Summary

The purpose of the study is to examine the effects of cognitive training on emotion regulation, impulse control, and aggression in people with schizophrenia. The study compares a combination of computerized cognitive remediation and social cognition training (CRT+SCT) to cognitive remediation alone (CRT). Study outcomes include multiple measures of aggression, emotion regulation, impulse control, cognition, and symptoms.

Detailed Description

Neurocognitive and social cognitive impairments are contributors to negative emotionality and impulsive aggression in people with schizophrenia. Impulsive aggression poses several challenges to the care of people with schizophrenia. These include a greater risk of rehospitalization and longer hospital stays, involvement with the criminal justice system, and increased risk of recidivism. The investigators recently found that schizophrenia patients with aggression history experienced improvements in neurocognition as well as decreased hostility/agitation and incidents of verbal and physical aggression after participating in cognitive remediation training (CRT). Based on these findings, it is hypothesized that improving neurocognition through CRT may have enhanced the capacity of schizophrenia patients to inhibit aggression through improved emotion regulation capacity and impulse control. It is also postulated that the addition of Social Cognition Training (SCT) to CRT would provide greater benefits on emotion regulation and impulse control over CRT alone. To test the hypotheses, the investigators will conduct a clinical trial that compares two configurations of cognitive training--CRT plus SCT versus CRT plus control computer games. The goal of the study is to examine the comparative benefits of the two configurations of cognitive training on outcomes that include neurocognition, social cognition, emotion regulation, impulse control, and reactive aggression. Participants assigned to the CRT plus SCT group will complete 24 hours of CRT and 12 hours of SCT. Participants assigned to the CRT only group will complete 24 hours of CRT and 12 hours of control computer activities. Emotion regulation, impulse control, and reactive aggression will be indexed using laboratory-based challenges. The investigators will recruit and characterize 90 study participants on demographic and clinical variables including age, gender, education, aggression history, and medications. Study outcome measures will be administered at baseline and posttreatment to participants randomized to the study groups. In a subsample of 32 patients, the study investigators will further examine changes in the neural network of emotion regulation and impulsivity before and after cognitive training.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •diagnosis of schizophrenia or schizo-affective disorder
  • •Age 18-60
  • •Mini Mental Status Exam score greater/equal to 24 at screening
  • •Auditory and visual acuity adequate to complete cognitive tests
  • •At least a score of 5 or more on the Life History of Aggression (LHA) aggression items or one confirmed assault in the past year
  • •Capacity and willingness to give consent

Exclusion Criteria

  • •Inability to read or speak English
  • •Documented significant disease of the Central Nervous System (CNS)
  • •History of intellectual impairment predating psychosis (e.g., a diagnosis of developmental disability)

Arms & Interventions

Cognitive Remediation (CRT)

Active Comparator

Participants assigned to CRT alone will complete 24 hours of neurocognitive training activities and 12 hours of control computer activities.

Intervention: Cognitive Remediation (CRT) (Behavioral)

CRT+ Social Cognition Training

Experimental

Participants assigned to the combination of CRT and SCT will complete 24 hours of computerized neurocognitive training in memory, attention, and processing speed, and 12 hours of computerized social cognition training focused on improving emotion recognition, social perspective taking, and mentalizing abilities.

Intervention: CRT+ Social Cognition Training (Behavioral)

Outcomes

Primary Outcomes

Change in Aggression

Time Frame: Change from baseline in aggression measures up to the end of intervention at 4 months

Overt Aggression Scale-Modified (OAS-M); Taylor Aggression Paradigm (TAP); Point Subtraction Aggression Paradigm (PSAP).

Secondary Outcomes

  • Change in Emotionality(Change from baseline in emotionality measures up to the end of intervention at 4 months)
  • Change in cognitive outcomes(Change from baseline in cognition measures up to the end of intervention at 4 months)
  • Change in Emotion Regulation Capacity(Change from baseline in measures up to the end of intervention at 4 months)
  • Change in Impulse Control(Change from baseline in impulse control measures up to the end of intervention at 4 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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